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British regulators spent less time investigating medical-device makers for device-related adverse events last year, and half of those investigations were completed within 12 weeks in 2007 instead of up to 17 weeks in 2006, according to the country's Medicines and Healthcare products Regulatory Agency.

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The Global Harmonization Task Force is seeking comments from stakeholders on a proposal to create a global unique device identification system to help reduce device-related errors and improve product identification during adverse events, among other goals. The task force has set a March 31 deadline for feedback on the proposal.

The FDA issued an import alert on several products from Cochlear Bone Anchored Solutions after the Swedish firm was found to have breached the agency's requirements for adverse-event reporting. Cochlear has sent two letters to the FDA expressing disagreement with the decision, but the agency deemed the response inadequate.

The FDA has released a final rule that explains when device makers can modify the labels of their products without prior approval from the agency. The rule, which will go into effect on Sept. 22, states that label changes will be allowed only when they are based on recently acquired data, such as those from adverse-event reports, new clinical trials and analyses of previously submitted information, the FDA said.

The FDA has released a final rule that explains when device makers can modify the labels of their products without prior approval from the agency. The rule, which will go into effect on Sept. 22, states that label changes will be allowed only when they are based on recently acquired data, such as those from adverse-event reports, new clinical trials and analyses of previously submitted information, the FDA said.